Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12, in the reply filed on June 27/2025 is acknowledged.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/328,057, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The provisional application 63/358,057 (filed 04/06/2022) does not provide support for at least some of the subject matter of the instant claims.
Claim 1 requires “an amount of vitamin A in the composite particle is a first concentration after production of the particle and a second concentration after exposing the composite particle to both a shelf-life test at 40*C for 4 weeks and a cooking test in water at 90*C for 2 hours, and the second concentration is more than 60% of the first concentration”. The provisional application does not provide support for this limitation. The instant specification provides Figures 9 and 11 in support of this limitation, but these figures are not found in the provisional application. In other words, there is support for a second concentration of more than 60% of the first concentration for one or the other of these tests (storage or cooking) but no support for a composite particle that has been subjected to both tests that maintains a 60% or greater concentration. As currently worded, claim 1 requires the concentration after both the exposing (storage) test and a cooking test.
Furthermore, the provisional application on page 6 provides a chart comparing PFH-BHT, PFH-TOC and BASF-TOC. There is no clear disclosure as to the composition of each of these materials. PFH is taken to mean Particles for Humanity and represents the inventive examples but this does not provide support for specific materials used. BHT is understood to be butylated hydroxytoluene as stated in the chart on page 4 of the provisional. TOC is understood to be tocopherol (also from page 4). BASF is understood to be some commercially available material. However, there is no disclosure of how the inventive examples are made or what contents of materials are used. Thus, other than the presence of Vitamin A, polymethacrylate polymer and TOC or BHT, the charts are not seen to specify the presence of other materials or the manner in which they are made.
Furthermore, there are no details are given regarding the materials of the used. The provisional application does not appear to support BMC as recited in claim 6. Claim 1 of the provisional recites polymethacrylate but does not specify BMC.
Regarding instant claims 7-9, no disclosure of a D50 for the subparticles/subdroplets or the particle diameter is found in the provisional application and no standard deviation is found for the latter. Claim 10 of the provisional application refers to the microparticles having an average diameter of between 100-500 microns. However, claim 8 requires the composite particle have a median volume diameter, D50, of between 1-1000 microns. Average diameter is not the same as median volume diameter (D50) and the range of 100-500 microns does not support a range of 1-1000 microns.
Regarding claim 10, while claims 5 and 11 of the provisional refer to the presence of ascorbic acid, it is not clear if this is intended to also indicate the presence of Vitamin C. There is no express mention of Vitamin C found in the provisional application, thus it appears to be attributed to the presence of ascorbic acid. If this is inaccurate, please clarify.
Regarding claim 12, no disclosure of the materials claimed can be found in the provisional application.
Accordingly, claims 1-10 are not entitled to the benefit of the prior application and the claims as currently drafted are given an effective priority date of 04/06/2023.
Claim Objections
Claims 3 and 6 are objected to because of the following informalities: claim 3 recites BHT and BHA without the corresponding meaning and claim 6 recites “BMC” but also does not properly write out the meaning of the acronym. BHA and BHT are understood as butylated hydroxytoluene and butylated hydroxyanisole, respectively. As best understood, it appears BMC means “basic methacrylate copolymer” as disclosed in [0028] of the instant specification. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 depends from claim 7 and requires the composite particle have a standard deviation of the volume diameter of less than 50 microns. Claim 7 limits the median volume diameter of the subparticles/subdroplets to between 50 nm and 2 microns. It is not clear how a particle size range of 50 nm to 2 microns could reasonably have a standard deviation which can reach the level of 50 microns. Should claim 9 depend from claim 8 which limits the median volume diameter of the composite particle, rather than the subparticles/subdroplets to between 1-1000 microns? For the purpose of examination, claim 9 is interpreted as being dependent upon either claim 8 (as appears to be what was intended) as well as claim 7 (as written).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-6, 11 and 12 are rejected under 35 U.S.C. 102(a)(2)) as anticipated by GRAS Notice 710 (2017) (referred to herein as GRAS).
GRAS teaches a pH sensitive polymer (BMC) is used to provide a protective coating on micronutrients and specifically teaches Vitamin A (section 6.2). GRAS states that when encapsulated, the micronutrients (Vitamin A) were not released into boiling water over 2 hours. The disclosure that the micronutrients were not released is considered to meet the claimed property of maintaining 60% of the concentration of Vitamin A when subjected to boiling for 2hrs and is reasonably expected to also meet the shelf-life test since the same material is discloses as that which is claimed. No surfactants are disclosed as being used by GRAS. GRAS discloses that the use of BMC enables a broad array of foods to be fortified and notes that bouillon is difficult because it needs to be boiled. The use of BMC protects micronutrients from elevated temperature, thus clearly indicating use in foods that are boiled, including bouillon. GRAS also teaches the addition of Vitamin A to milk (3.1).
Claims 1, 4-6 and 12 are rejected under 35 U.S.C. 102(a)(1)) as anticipated by US 2019/0200664 (Anselmo).
Regarding claims 1, 5 and 6, Anselmo teaches particulate formulations containing one or more micronutrients such as vitamin A (abstract). Anselmo teaches the use of pH-sensitive, thermally stable polymers including BMC [0100, 0105]. Figure 1B of Anselmo illustrates the one step process of forming the composite particle comprising a fat-soluble micronutrient (vitamin) and a pH-sensitive polymer. As illustrated, subparticles of the fat-soluble vitamin are present in the polymer, thus meeting the subparticles or subdroplets embedded in the pH sensitive polymer.
The criteria for stability of the fat-soluble vitamins, such as Vitamin A, is to not lose more than 50%, 60%, 70% or more of its bioactivity when exposed to boiling water for 2 hours or subjected to long term (60 days) exposure to 75% humidity and 40C [0038]. This testing is commensurate with that of instant claim 1 and while Anselmo discloses the testing separately, the materials of Anselmo are essentially the same as that claimed, thus one of ordinary skill would reasonably expect the materials to have the same performance. An example of retinyl palmitate incorporated into EPO-MPs via O/W emulsion and when subjected to boiling conditions, no release of Vitamin A was detected [0209]. Moreover, Figure 9C discloses VitA-EPO having a recovery % of approximately 60% on day 28 when stored at 40C and Figure 5D shows a % cumulative release of Vitamin A of less than 10% after 2hrs boiling at 100C.
Regarding the presence of mineral acids, the method of Anselmo does not disclose use of any mineral acids. Regarding the presence of organic solvents, Anselmo does teach that the solvent for the solution of the pH sensitive polymer is an organic solvent [0133]; however, Anselmo also teaches solvent removal [0133, claim 22]. Moreover, the phrase “essentially free” is considered to allow for the presence of residuals.
Regarding claim 4, Anselmo does not expressly disclose the use of surfactants.
Regarding claim 12, Anselmo teaches incorporation o f the formulations into a variety of food vehicles including wheat flour and sugar [0151] and also teaches incorporation into milk and corn meal [0157].
Claim 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Anselmo in view of EP 1106174 (Chen).
Anselmo teaches a composite particle having subparticles of Vitamin A encapsulated in a polymer as discussed above but does not expressly teach the size of the subparticles.
Chen teaches powder compositions of fat-soluble vitamins where droplets of a fat-soluble vitamin are dispersed in a matrix. The fat-soluble vitamin may be Vitamin A and the matrix is an emulsifier [0025] such as a polysaccharide gum. The droplets of the vitamin within the matrix have an average diameter of 70-120nm [0025].
Anselmo teaches that a material such as polysaccharides can be used as a matrix to encapsulate the water-soluble micronutrients (vitamins) which can be further coated or encapsulated by one or more pH-sensitive polymers [0099]. It would have been obvious to one of ordinary skill that a viable size of the vitamin drops that are formed within the matrix of Anselmo would be on the order of the size taught by Chen. Chen teaches that the size of the droplets formed in the matrix of polysaccharide gum is 70-120 nm and is effective for delivering vitamin nutrients. One of ordinary skill would have found it obvious to provide a similar droplet size for the vitamins in the matrix of Anselmo with a reasonable expectation of successfully providing a vitamin nutrient for delivery to a consumer. Having all of the particle sizes within the range of 80-120 nm would provide a D50 between 50nm and 2 microns as well as a deviation of less than 50 microns. Additionally, while not expressed as a median volume diameter, one of ordinary skill would have found it obvious to provide a homogenous droplet size based upon the desire in Chen for optical clarity as discussed in [0014].
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Anselmo.
Anselmo gives an example of Vitamin A microparticles having an average particle size of 30-500 microns [0295] and also EPO-MPs having a size of 214 +/- 16 microns. While not expressly disclosed as a median volume diameter, it would have been obvious to one of ordinary skill in the art to provide the particles with a uniform size based upon the disclosure of a deviation of 16 microns relative to 214 microns. The teaching of +/- 16 is also seen to obviate a deviation of less than 50 microns.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Anselmo in view of GRAS Notice 710 (2017) (referred to herein as GRAS).
Anselmo teaches addition of the Vitamin A composite particle to various foods but does not teach adding the composite particles to bouillon. GRAS teaches basic methacrylate copolymer is used to coat various micronutrients, such as Vitamin A, and that many foods are difficult to fortify because they need to be cooked or boiled, and an example of bouillon is given (section 3.1). Since Anselmo teaches a Vitamin A composite particle that is able to maintain viability of the vitamin under boiling conditions, it would have been obvious to add the composite particles of Anselmo to bouillon with a reasonable expectation that the vitamin will be able to withstand boiling and achieve delivery of the micronutrient to a consumer.
Claim 2, 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Anselmo in view of WO 2021/165288 (Musaeus).
Anselmo teaches a composite particle having subparticles of Vitamin A, in the form of retinyl palmitate [Anselmo, 0278], encapsulated in a polymer as discussed above but does not expressly teach the presence of ascorbic acid, maltodextrin, and modified starch as recited in claim 2, or one of ascorbic acid, BHT, BHA or tocopherol as recited in claim 3. Anselmo does teach that a material such as polysaccharides can be used as a matrix to encapsulate the water-soluble micronutrients (vitamins) which can be further coated or encapsulated by one or more pH-sensitive polymers [ Anselmo, 0099].
Musaeus teaches stable fat-soluble vitamin powders, including Vitamin A. The powder formulations may include antioxidants such as sodium ascorbate (salt of ascorbic acid) and tocopherol (page 2) as well as a hydrocolloid as emulsifier and matrix component (page 2).
It would have been obvious to one of ordinary skill to add antioxidants, such as sodium ascorbate and tocopherol, to prevent oxidation of Vitamin A and extend the lifetime of the nutrient. Regarding the use of the salt of ascorbic acid, this is seen to be an obvious alternative to ascorbic acid and the use of the acid or the salt thereof would yield predictable results in use as an antioxidant. The presence of ascorbic acid or its salt is considered to meet the presence of Vitamin C required by instant claim 10.
Musaeus and Anselmo teach the use of polysaccharides as a matrix component and Musaeus further discloses modified food starch (page 2) and maltodextrin which can function as both matrix and plasticizer (page 3). It would have been obvious to use polysaccharides in the form of modified starch and maltodextrin in Anselmo as disclosed by Musaeus as both references disclose the use of polysaccharides as matrix material for encapsulation of Vitamin A and Musaeous further specifically discloses modified food starch and maltodextrin thereby demonstrating their known use and establishing a reasonable expectation of successfully using these materials as polysaccharide matrix materials for encapsulation of Vitamin A. Furthermore, Example 1 of Musaeus teaches the powder comprises maltodextrin, modified food starch, vitamin A palmitate, sodium ascorbate, and tocopherol (page 5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER C MCNEIL whose telephone number is (571)272-1540. The examiner can normally be reached M-F 9-5.
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JENNIFER C. MCNEIL
Primary Examiner
Art Unit 1793
/Jennifer McNeil/ Primary Examiner, Art Unit 1793